Arsenic Trioxide and Radiation Therapy in Treating Young Patients With Newly Diagnosed Gliomas

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)

Overall Status

Completed

CT.gov ID

NCT00095771

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for patients with glioma. Drugs such as arsenic trioxide may also make the tumor cells more sensitive to radiation therapy. Combining arsenic trioxide with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining arsenic trioxide with radiation therapy in treating patients who have newly diagnosed gliomas.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: arsenic trioxide Radiation: radiation therapy	Phase 1

Detailed Description

OBJECTIVES:

Determine the maximum tolerated dose of arsenic trioxide when administered with radiotherapy in pediatric patients with newly diagnosed anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, or intrinsic pontine glioma.
Determine the toxicity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of arsenic trioxide (ATO).

Patients undergo radiotherapy once daily, 5 days a week, for approximately 6 weeks. Patients concurrently receive ATO IV over 1 hour, 1-5 times weekly, for approximately 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of ATO until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 3-36 months.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Primary Purpose:

Treatment

Official Title:

A Phase I Trial of Arsenic Trioxide in the Treatment of Infiltrating Gliomas of Childhood

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose as assessed by NCI CTCAE v. 3.0 following study completion []
Safety as assessed by NCI CTCAE v. 3.0 following study completion []

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of 1 of the following:
Clinical and neuroradiographic findings consistent with intrinsic pontine glioma
Histologically confirmed anaplastic astrocytoma, glioblastoma multiforme, or gliosarcoma
Multifocal high-grade gliomas allowed
No exophytic tumors
No focal lesions
No underlying diagnosis of neurofibromatosis
No tumors originating in anatomic structures adjacent to the cerebellar peduncle or cervical medullary junction

PATIENT CHARACTERISTICS:

Age

3 to 21

Performance status

Karnofsky 60-100% OR
Lansky 60-100%

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count > 1,500/mm^3
Hemoglobin > 10 g/dL
Platelet count > 100,000/mm^3

Hepatic

Bilirubin < 2.0 mg/dL
Alkaline phosphatase < 2.5 times upper limit of normal (ULN)
Transaminases < 2.5 times ULN

Renal

Creatinine < 2.0 times ULN

Cardiovascular

No second-degree heart block
No absolute QTc interval > 500 msec with normal potassium and magnesium levels

Other

Not pregnant or nursing
Negative pregnancy test
No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ
No other serious medical illness
Able to undergo MRI

PRIOR CONCURRENT THERAPY:

Biologic therapy

More than 28 days since prior biologic therapy
No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])

Chemotherapy

No prior arsenic trioxide

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Prior surgery for the brain tumor allowed

Other

No other prior therapy for the brain tumor
More than 28 days since prior investigational drugs or devices
No concurrent amphotericin B

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)

Investigators

Study Chair: Kenneth J. Cohen, MD, MBA, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00095771

Other Study ID Numbers:

CDR0000393829
P30CA006973
JHOC-J0423
JHOC-04041906

First Posted:

Nov 9, 2004

Last Update Posted:

Apr 22, 2011

Last Verified:

Apr 1, 2011

Keywords provided by , ,

untreated childhood brain stem glioma

childhood high-grade cerebral astrocytoma

Additional relevant MeSH terms:

Glioma

Nervous System Neoplasms

Central Nervous System Neoplasms

Arsenic Trioxide

Study Results

No Results Posted as of Apr 22, 2011